A Study of the Safety and Efficacy of Posaconazole Versus... | NCT01782131

ID	Type	Description	Link
5592-069	Other Identifier	Merck
2011-003938-14	EudraCT Number

Label	Type	Description	Intervention Names
Posaconazole (POS)	Experimental	Participants received 300 mg posaconazole (POS) intravenous (IV) twice per day (BID) on Day 1, and then received 300 mg POS IV plus placebo IV once per day (QD) starting on Day 2 until clinically stable when participants transitioned to oral POS tablets plus oral placebo tablets QD for up to 12 weeks of treatment. Most participants were expected to initiate treatment with IV therapy and transition to oral therapy as clinically indicated, with some participants initiating treatment with oral therapy, per clinical judgment.	Drug: Posaconazole Drug: Placebo
Voriconazole	Active Comparator	Participants received 6 mg/kg voriconazole (VOR) IV twice per day (BID) on Day 1, and then received 4 mg/kg VOR IV BID on Day 2 until clinically stable when participants transitioned to oral therapy with VOR capsules or VOR placebo capsules BID for up to 12 weeks of treatment. Most participants were expected to initiate treatment with IV therapy and transition to oral therapy as clinically indicated, with some participants initiating treatment with oral therapy, per clinical judgment.	Drug: Voriconazole Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Posaconazole	Drug	POS IV: Day 1: 300 mg BID Day 2-84: 300 mg QD POS oral: Day 1: 300 mg BID Day 2-84: 300 mg QD	Posaconazole (POS)

Measure	Description	Time Frame
Percentage of Participants Who Died Through Day 42 in the Intention to Treat Population	The percentage of participants who died with posaconazole (POS) compared to voriconazole (VOR) in the first line treatment of invasive aspergillosis (IA) in the Intention to Treat (ITT) population through Day 42 was assessed.	Up to ~42 days

Measure	Description	Time Frame
Percentage of Participants Who Died Through Day 42 in the Full Analysis Set Population	The percentage of participants who died with POS compared to VOR in the first line treatment of invasive aspergillosis (IA) in the Full Analysis Set (FAS) population through Day 42 was assessed.	Up to ~42 days
Percentage of Participants Who Died Through Day 84 in the ITT Population

Name	Affiliation	Role
Medical Director	Merck Sharp & Dohme LLC	Study Director

PubMed Identifier	Type	Citation	Retractions
37676612	Result	Maertens JA, Rahav G, Lee DG, Haider S, Ramirez-Sanchez IC, Klimko N, Ponce-de-Leon A, Han S, Wrishko R, Winchell GA, Grandhi A, Waskin H; study investigators. Pharmacokinetic and Exposure Response Analysis of the Double-Blind Randomized Study of Posaconazole and Voriconazole for Treatment of Invasive Aspergillosis. Clin Drug Investig. 2023 Sep;43(9):681-690. doi: 10.1007/s40261-023-01282-7. Epub 2023 Sep 7.
33549194

ID	Title	Description
FG000	Posaconazole	Participants received 300 mg posaconazole (POS) intravenous (IV) twice per day (BID) on Day 1, and then received 300 mg POS IV plus placebo IV once per day (QD) starting on Day 2 until clinically stable when participants transitioned to oral POS tablets plus oral placebo tablets QD for up to 12 weeks of treatment. Most participants were expected to initiate treatment with IV therapy and transition to oral therapy as clinically indicated, with some participants initiating treatment with oral therapy, per clinical judgment.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Feb 7, 2019

ID	Title	Description
BG000	Posaconazole	Participants received 300 mg posaconazole (POS) intravenous (IV) twice per day (BID) on Day 1, and then received 300 mg POS IV plus placebo IV once per day (QD) starting on Day 2 until clinically stable when participants transitioned to oral POS tablets plus oral placebo tablets QD for up to 12 weeks of treatment. Most participants were expected to initiate treatment with IV therapy and transition to oral therapy as clinically indicated, with some participants initiating treatment with oral therapy, per clinical judgment.
BG001	Voriconazole	Participants received 6 mg/kg voriconazole (VOR) IV twice per day (BID) on Day 1, and then received 4 mg/kg VOR IV BID on Day 2 until clinically stable when participants transitioned to oral therapy with VOR capsules or VOR placebo capsules BID for up to 12 weeks of treatment. Most participants were expected to initiate treatment with IV therapy and transition to oral therapy as clinically indicated, with some participants initiating treatment with oral therapy, per clinical judgment.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000288 BG001287 BG002575

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants Who Died Through Day 42 in the Intention to Treat Population

The percentage of participants who died with posaconazole (POS) compared to voriconazole (VOR) in the first line treatment of invasive aspergillosis (IA) in the Intention to Treat (ITT) population through Day 42 was assessed.

The analysis population consisted of all randomized participants who received at least one dose of study treatment.

Posted

Number

Percentage of Participants

Up to ~42 days

ID	Title	Description
OG000	Posaconazole	Participants received 300 mg posaconazole (POS) intravenous (IV) twice per day (BID) on Day 1, and then received 300 mg POS IV plus placebo IV once per day (QD) starting on Day 2 until clinically stable when participants transitioned to oral POS tablets plus oral placebo tablets QD for up to 12 weeks of treatment. Most participants were expected to initiate treatment with IV therapy and transition to oral therapy as clinically indicated, with some participants initiating treatment with oral therapy, per clinical judgment.
OG001	Voriconazole	Participants received 6 mg/kg voriconazole (VOR) IV twice per day (BID) on Day 1, and then received 4 mg/kg VOR IV BID on Day 2 until clinically stable when participants transitioned to oral therapy with VOR capsules or VOR placebo capsules BID for up to 12 weeks of treatment. Most participants were expected to initiate treatment with IV therapy and transition to oral therapy as clinically indicated, with some participants initiating treatment with oral therapy, per clinical judgment.

Units	Counts
Participants	OG000288 OG001287

Title

Denominators

Categories

Title	Measurements
	OG00015.3 OG00120.6

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Miettinen and Nurminen		<.0001		Estimated Difference in Percent	-5.3			2-Sided	95	-11.6	1.0					Non-Inferiority	Based on Miettinen and Nurminen's method stratified by the risk for mortality/poor outcome (high risk, not high risk) and using Cochran-Mantel-Haenszel weighting scheme. The p-Value is based on the one-sided non-inferiority test. Non-inferiority of posaconazole vs. voriconazole is established if the upper limit of the 95% confidence interval is less than 10%.

Secondary

Percentage of Participants Who Died Through Day 42 in the Full Analysis Set Population

The percentage of participants who died with POS compared to VOR in the first line treatment of invasive aspergillosis (IA) in the Full Analysis Set (FAS) population through Day 42 was assessed.

The analysis population consisted of all randomized participants who have been classified as having proven or probable IA (based upon independent adjudication assessment using the modified 2008 European Organization for Research and Treatment of Cancer/Mycoses study group [EORTC/MSG] definitions) and received at least one dose of study drug.

Posted

Number

Percentage of Participants

Up to ~42 days

ID	Title	Description
OG000	Posaconazole	Participants received 300 mg posaconazole (POS) intravenous (IV) twice per day (BID) on Day 1, and then received 300 mg POS IV plus placebo IV once per day (QD) starting on Day 2 until clinically stable when participants transitioned to oral POS tablets plus oral placebo tablets QD for up to 12 weeks of treatment. Most participants were expected to initiate treatment with IV therapy and transition to oral therapy as clinically indicated, with some participants initiating treatment with oral therapy, per clinical judgment.
OG001	Voriconazole	Participants received 6 mg/kg voriconazole (VOR) IV twice per day (BID) on Day 1, and then received 4 mg/kg VOR IV BID on Day 2 until clinically stable when participants transitioned to oral therapy with VOR capsules or VOR placebo capsules BID for up to 12 weeks of treatment. Most participants were expected to initiate treatment with IV therapy and transition to oral therapy as clinically indicated, with some participants initiating treatment with oral therapy, per clinical judgment.

Secondary

Percentage of Participants Who Died Through Day 84 in the ITT Population

The percentage of participants who died with POS compared to VOR in the first line treatment of invasive aspergillosis (IA) in the ITT population through Day 84 was assessed.

The analysis population consisted of all randomized participants who received at least one dose of study treatment.

Posted

Number

Percentage of Participants

Up to ~84 days

ID	Title	Description
OG000	Posaconazole	Participants received 300 mg posaconazole (POS) intravenous (IV) twice per day (BID) on Day 1, and then received 300 mg POS IV plus placebo IV once per day (QD) starting on Day 2 until clinically stable when participants transitioned to oral POS tablets plus oral placebo tablets QD for up to 12 weeks of treatment. Most participants were expected to initiate treatment with IV therapy and transition to oral therapy as clinically indicated, with some participants initiating treatment with oral therapy, per clinical judgment.
OG001	Voriconazole	Participants received 6 mg/kg voriconazole (VOR) IV twice per day (BID) on Day 1, and then received 4 mg/kg VOR IV BID on Day 2 until clinically stable when participants transitioned to oral therapy with VOR capsules or VOR placebo capsules BID for up to 12 weeks of treatment. Most participants were expected to initiate treatment with IV therapy and transition to oral therapy as clinically indicated, with some participants initiating treatment with oral therapy, per clinical judgment.

Secondary

Percentage of Participants Who Died Through Day 84 in the FAS Population

The percentage of participants who died with POS compared to VOR in the first line treatment of invasive aspergillosis (IA) in the FAS population through Day 84 was assessed.

Posted

Number

Percentage of Participants

Up to ~ 84 days

ID	Title	Description
OG000	Posaconazole	Participants received 300 mg posaconazole (POS) intravenous (IV) twice per day (BID) on Day 1, and then received 300 mg POS IV plus placebo IV once per day (QD) starting on Day 2 until clinically stable when participants transitioned to oral POS tablets plus oral placebo tablets QD for up to 12 weeks of treatment. Most participants were expected to initiate treatment with IV therapy and transition to oral therapy as clinically indicated, with some participants initiating treatment with oral therapy, per clinical judgment.
OG001	Voriconazole	Participants received 6 mg/kg voriconazole (VOR) IV twice per day (BID) on Day 1, and then received 4 mg/kg VOR IV BID on Day 2 until clinically stable when participants transitioned to oral therapy with VOR capsules or VOR placebo capsules BID for up to 12 weeks of treatment. Most participants were expected to initiate treatment with IV therapy and transition to oral therapy as clinically indicated, with some participants initiating treatment with oral therapy, per clinical judgment.

Secondary

Percentage of Participants Achieving Global Clinical Response at Week 12 in the FAS Population

The global clinical response of POS compared to VOR in the first line treatment of invasive aspergillosis (IA) was assessed. The percentage of participants achieving adjudicated global clinical response (complete or partial) at Week 12 was reported. Complete response was classified as survival with resolution of fungal disease evidence; Partial response was survival and improvement of fungal disease.

Posted

Number

Percentage of Participants

Up to 12 weeks (± 4 weeks)

ID	Title	Description
OG000	Posaconazole	Participants received 300 mg posaconazole (POS) intravenous (IV) twice per day (BID) on Day 1, and then received 300 mg POS IV plus placebo IV once per day (QD) starting on Day 2 until clinically stable when participants transitioned to oral POS tablets plus oral placebo tablets QD for up to 12 weeks of treatment. Most participants were expected to initiate treatment with IV therapy and transition to oral therapy as clinically indicated, with some participants initiating treatment with oral therapy, per clinical judgment.
OG001	Voriconazole

Secondary

Percentage of Participants Achieving Global Clinical Response at Week 6 in the FAS Population

The global clinical response of POS compared to VOR in the first line treatment of invasive aspergillosis (IA) was assessed. The percentage of participants achieving adjudicated global clinical response (complete or partial) at Week 6 was reported. Complete response was classified as survival with resolution of fungal disease evidence; Partial response was survival and improvement of fungal disease.

Posted

Number

Percentage of Participants

Up to 6 weeks (± 2 weeks)

ID	Title	Description
OG000	Posaconazole	Participants received 300 mg posaconazole (POS) intravenous (IV) twice per day (BID) on Day 1, and then received 300 mg POS IV plus placebo IV once per day (QD) starting on Day 2 until clinically stable when participants transitioned to oral POS tablets plus oral placebo tablets QD for up to 12 weeks of treatment. Most participants were expected to initiate treatment with IV therapy and transition to oral therapy as clinically indicated, with some participants initiating treatment with oral therapy, per clinical judgment.
OG001	Voriconazole

Secondary

Number of Participants Experiencing Mortality at Day 42, Day 84, and Day 114 in the FAS Population (Kaplan-Meier Time To Death Estimate)

The number of participants experiencing mortality at Day 42, Day 84 and Day 114 in participants with proven or probable IA receiving POS versus VOR were assessed. The Kaplan-Meier estimate reports the number of participants who experienced death (all causes) through Day 114 or ~16 weeks. Participants who did not have any endpoint event until last visit or who were lost to follow-up and had no event were censored at the time of last available information (last study visit). For Day 42 and Day 84, missing or 'unable to determine' responses were considered as failures (dead).

Posted

Count of Participants

Participants

Up to ~16 weeks (± 2 weeks)

ID	Title	Description
OG000	Posaconazole	Participants received 300 mg posaconazole (POS) intravenous (IV) twice per day (BID) on Day 1, and then received 300 mg POS IV plus placebo IV once per day (QD) starting on Day 2 until clinically stable when participants transitioned to oral POS tablets plus oral placebo tablets QD for up to 12 weeks of treatment. Most participants were expected to initiate treatment with IV therapy and transition to oral therapy as clinically indicated, with some participants initiating treatment with oral therapy, per clinical judgment.

Secondary

Number of Participants Who Died Due to Invasive Aspergillosis Through Day 42 in the FAS Population

The number of participants who died due to IA receiving POS versus VOR through Day 42 was assessed.

All randomized participants who died by Day 42 and who have been classified as having proven or probable IA (based upon independent adjudication assessment using the modified 2008 European Organization for Research and Treatment of Cancer/Mycoses study group [EORTC/MSG] definitions), and received at least one dose of study drug.

Posted

Count of Participants

Participants

Up to 42 days

ID	Title	Description
OG000	Posaconazole	Participants received 300 mg posaconazole (POS) intravenous (IV) twice per day (BID) on Day 1, and then received 300 mg POS IV plus placebo IV once per day (QD) starting on Day 2 until clinically stable when participants transitioned to oral POS tablets plus oral placebo tablets QD for up to 12 weeks of treatment. Most participants were expected to initiate treatment with IV therapy and transition to oral therapy as clinically indicated, with some participants initiating treatment with oral therapy, per clinical judgment.
OG001	Voriconazole	Participants received 6 mg/kg voriconazole (VOR) IV twice per day (BID) on Day 1, and then received 4 mg/kg VOR IV BID on Day 2 until clinically stable when participants transitioned to oral therapy with VOR capsules or VOR placebo capsules BID for up to 12 weeks of treatment. Most participants were expected to initiate treatment with IV therapy and transition to oral therapy as clinically indicated, with some participants initiating treatment with oral therapy, per clinical judgment.

Secondary

Number of Participants Who Died Due to Invasive Aspergillosis Through Day 84 in the FAS Population

The number of participants who died due to IA receiving POS versus VOR in the FAS population through Day 84 was assessed.

All randomized participants who died by Day 84 and who have been classified as having proven or probable IA (based upon independent adjudication assessment using the modified 2008 European Organization for Research and Treatment of Cancer/Mycoses study group [EORTC/MSG] definitions), and received at least one dose of study drug.

Posted

Count of Participants

Participants

Up to 84 days

ID	Title	Description
OG000	Posaconazole	Participants received 300 mg posaconazole (POS) intravenous (IV) twice per day (BID) on Day 1, and then received 300 mg POS IV plus placebo IV once per day (QD) starting on Day 2 until clinically stable when participants transitioned to oral POS tablets plus oral placebo tablets QD for up to 12 weeks of treatment. Most participants were expected to initiate treatment with IV therapy and transition to oral therapy as clinically indicated, with some participants initiating treatment with oral therapy, per clinical judgment.
OG001	Voriconazole	Participants received 6 mg/kg voriconazole (VOR) IV twice per day (BID) on Day 1, and then received 4 mg/kg VOR IV BID on Day 2 until clinically stable when participants transitioned to oral therapy with VOR capsules or VOR placebo capsules BID for up to 12 weeks of treatment. Most participants were expected to initiate treatment with IV therapy and transition to oral therapy as clinically indicated, with some participants initiating treatment with oral therapy, per clinical judgment.

Secondary

Percentage of Participants With Tier 1 Treatment Emergent Adverse Events

The percentage of participants with Tier 1 treatment-emergent adverse events (TEAEs) was determined. The Tier 1 TEAEs included hepatic safety (elevated aspartate serum transaminase [AST] or alanine serum transaminase [ALT] value ≥3x upper limit of normal (ULN) and an elevated total bilirubin value ≥2x ULN and, at the same time, an alkaline phosphatase value <2 ULN); central nervous system (CNS) and visual disturbances (eye disorders, nervous system disorders, psychiatric disorders), dermatologic reactions, and adrenal insufficiency or temporally associated TEAEs of hypotension.

The analysis population consisted of all participants who received at least one dose of study treatment.

Posted

Number

Percentage of Participants

Up to ~16 weeks (± 2 weeks)

ID	Title	Description
OG000	Posaconazole	Participants received 300 mg posaconazole (POS) intravenous (IV) twice per day (BID) on Day 1, and then received 300 mg POS IV plus placebo IV once per day (QD) starting on Day 2 until clinically stable when participants transitioned to oral POS tablets plus oral placebo tablets QD for up to 12 weeks of treatment. Most participants were expected to initiate treatment with IV therapy and transition to oral therapy as clinically indicated, with some participants initiating treatment with oral therapy, per clinical judgment.
OG001	Voriconazole	Participants received 6 mg/kg voriconazole (VOR) IV twice per day (BID) on Day 1, and then received 4 mg/kg VOR IV BID on Day 2 until clinically stable when participants transitioned to oral therapy with VOR capsules or VOR placebo capsules BID for up to 12 weeks of treatment. Most participants were expected to initiate treatment with IV therapy and transition to oral therapy as clinically indicated, with some participants initiating treatment with oral therapy, per clinical judgment.

Secondary

Percentage of Participants With at Least One Adverse Event

An adverse event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product.

The analysis population consisted of all randomized participants who received at least one dose of study treatment.

Posted

Number

Percentage of Participants

Up to ~16 weeks (± 2 weeks)

ID	Title	Description
OG000	Posaconazole	Participants received 300 mg posaconazole (POS) intravenous (IV) twice per day (BID) on Day 1, and then received 300 mg POS IV plus placebo IV once per day (QD) starting on Day 2 until clinically stable when participants transitioned to oral POS tablets plus oral placebo tablets QD for up to 12 weeks of treatment. Most participants were expected to initiate treatment with IV therapy and transition to oral therapy as clinically indicated, with some participants initiating treatment with oral therapy, per clinical judgment.
OG001	Voriconazole	Participants received 6 mg/kg voriconazole (VOR) IV twice per day (BID) on Day 1, and then received 4 mg/kg VOR IV BID on Day 2 until clinically stable when participants transitioned to oral therapy with VOR capsules or VOR placebo capsules BID for up to 12 weeks of treatment. Most participants were expected to initiate treatment with IV therapy and transition to oral therapy as clinically indicated, with some participants initiating treatment with oral therapy, per clinical judgment.

Secondary

Percentage of Participants With at Least One Drug Related Adverse Event

The analysis population consisted of all randomized participants who received at least one dose of study treatment.

Posted

Number

Percentage of Participants

Up to ~16 weeks (± 2 weeks)

ID	Title	Description
OG000	Posaconazole	Participants received 300 mg posaconazole (POS) intravenous (IV) twice per day (BID) on Day 1, and then received 300 mg POS IV plus placebo IV once per day (QD) starting on Day 2 until clinically stable when participants transitioned to oral POS tablets plus oral placebo tablets QD for up to 12 weeks of treatment. Most participants were expected to initiate treatment with IV therapy and transition to oral therapy as clinically indicated, with some participants initiating treatment with oral therapy, per clinical judgment.
OG001	Voriconazole	Participants received 6 mg/kg voriconazole (VOR) IV twice per day (BID) on Day 1, and then received 4 mg/kg VOR IV BID on Day 2 until clinically stable when participants transitioned to oral therapy with VOR capsules or VOR placebo capsules BID for up to 12 weeks of treatment. Most participants were expected to initiate treatment with IV therapy and transition to oral therapy as clinically indicated, with some participants initiating treatment with oral therapy, per clinical judgment.

Secondary

Percentage of Participants With at Least One Serious Adverse Event

A serious adverse event (SAE) was an AE that resulted in death, was life threatening, required or prolonged an existing hospitalization, resulted in persistent or significant disability or incapacity, was a congenital anomaly or birth defect, or was another important medical event deemed such by medical or scientific judgment.

The analysis population consisted of all randomized participants who received at least one dose of study treatment.

Posted

Number

Percentage of Participants

Up to ~16 weeks (± 2 weeks)

ID	Title	Description
OG000	Posaconazole	Participants received 300 mg posaconazole (POS) intravenous (IV) twice per day (BID) on Day 1, and then received 300 mg POS IV plus placebo IV once per day (QD) starting on Day 2 until clinically stable when participants transitioned to oral POS tablets plus oral placebo tablets QD for up to 12 weeks of treatment. Most participants were expected to initiate treatment with IV therapy and transition to oral therapy as clinically indicated, with some participants initiating treatment with oral therapy, per clinical judgment.
OG001	Voriconazole	Participants received 6 mg/kg voriconazole (VOR) IV twice per day (BID) on Day 1, and then received 4 mg/kg VOR IV BID on Day 2 until clinically stable when participants transitioned to oral therapy with VOR capsules or VOR placebo capsules BID for up to 12 weeks of treatment. Most participants were expected to initiate treatment with IV therapy and transition to oral therapy as clinically indicated, with some participants initiating treatment with oral therapy, per clinical judgment.

Secondary

Percentage of Participants With at Least One Serious Drug Related Adverse Event

An SAE was an AE that resulted in death, was life threatening, required or prolonged an existing hospitalization, resulted in persistent or significant disability or incapacity, was a congenital anomaly or birth defect, or was another important medical event deemed such by medical or scientific judgment.

The analysis population consisted of all randomized participants who received at least one dose of study treatment.

Posted

Number

Percentage of Participants

Up to ~16 weeks (± 2 weeks)

ID	Title	Description
OG000	Posaconazole	Participants received 300 mg posaconazole (POS) intravenous (IV) twice per day (BID) on Day 1, and then received 300 mg POS IV plus placebo IV once per day (QD) starting on Day 2 until clinically stable when participants transitioned to oral POS tablets plus oral placebo tablets QD for up to 12 weeks of treatment. Most participants were expected to initiate treatment with IV therapy and transition to oral therapy as clinically indicated, with some participants initiating treatment with oral therapy, per clinical judgment.
OG001	Voriconazole	Participants received 6 mg/kg voriconazole (VOR) IV twice per day (BID) on Day 1, and then received 4 mg/kg VOR IV BID on Day 2 until clinically stable when participants transitioned to oral therapy with VOR capsules or VOR placebo capsules BID for up to 12 weeks of treatment. Most participants were expected to initiate treatment with IV therapy and transition to oral therapy as clinically indicated, with some participants initiating treatment with oral therapy, per clinical judgment.

Secondary

Percentage of Participants Who Discontinued Study Treatment Due to an Adverse Event

An AE was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product.

The analysis population consisted of all randomized participants who received at least one dose of study treatment.

Posted

Number

Percentage of Participants

Up to ~12 weeks

ID	Title	Description
OG000	Posaconazole	Participants received 300 mg posaconazole (POS) intravenous (IV) twice per day (BID) on Day 1, and then received 300 mg POS IV plus placebo IV once per day (QD) starting on Day 2 until clinically stable when participants transitioned to oral POS tablets plus oral placebo tablets QD for up to 12 weeks of treatment. Most participants were expected to initiate treatment with IV therapy and transition to oral therapy as clinically indicated, with some participants initiating treatment with oral therapy, per clinical judgment.
OG001	Voriconazole	Participants received 6 mg/kg voriconazole (VOR) IV twice per day (BID) on Day 1, and then received 4 mg/kg VOR IV BID on Day 2 until clinically stable when participants transitioned to oral therapy with VOR capsules or VOR placebo capsules BID for up to 12 weeks of treatment. Most participants were expected to initiate treatment with IV therapy and transition to oral therapy as clinically indicated, with some participants initiating treatment with oral therapy, per clinical judgment.

Secondary

Steady State Average Concentration (Cavg) of Posaconazole With Food Intake

The characterization of the pharmacokinetics (PK) parameters of POS was determined from plasma samples taken at steady-state after receiving oral tablet of POS. Steady-state Cavg, where Cavg is defined as area under the concentration time-curve from 0 to 24 hours (AUC0-24hr) divided by the dosing interval. Data is presented in POS group column only. No evaluation of food intake on the VOR capsule was presented.

The analysis population consisted of all randomized participants in the POS group only who received at least one dose of study treatment. Per protocol, the VOR group was not included in the analysis population because the food intake evaluation was limited to the POS group.

Posted

Mean

Standard Deviation

ng/mL

Baseline, and at pre-dose on Day 7, Week 2, Week 4, Week 6, and Week 12

ID	Title	Description
OG000	Posaconazole	Participants received 300 mg posaconazole (POS) intravenous (IV) twice per day (BID) on Day 1, and then received 300 mg POS IV plus placebo IV once per day (QD) starting on Day 2 until clinically stable when participants transitioned to oral POS tablets plus oral placebo tablets QD for up to 12 weeks of treatment. Most participants were expected to initiate treatment with IV therapy and transition to oral therapy as clinically indicated, with some participants initiating treatment with oral therapy, per clinical judgment.

Units

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected288 at risk EG0010 events0 affected287 at risk
Blood disorder	Blood and lymphatic system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Bone marrow failure	Blood and lymphatic system disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected288 at risk EG0013 events2 affected287 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 22.1	Systematic Assessment	EG00032 events24 affected288 at risk EG00126 events21 affected287 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected288 at risk EG0011 events1 affected287 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 22.1	Systematic Assessment	EG0002 events1 affected288 at risk EG0011 events1 affected287 at risk
Thrombotic thrombocytopenic purpura	Blood and lymphatic system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0011 events1 affected287 at risk
Accessory cardiac pathway	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Acute left ventricular failure	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Angina pectoris	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Arrhythmia	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected288 at risk EG0012 events2 affected287 at risk
Cardiac arrest	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0011 events1 affected287 at risk
Cardiac failure	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected288 at risk EG0011 events1 affected287 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0002 events1 affected288 at risk EG0011 events1 affected287 at risk
Left ventricular failure	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Myocardial infarction	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Vision blurred	Eye disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected288 at risk EG0010 events0 affected287 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Colitis	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected288 at risk EG0010 events0 affected287 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0013 events2 affected287 at risk
Duodenitis	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Gastric varices haemorrhage	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Gastritis	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0013 events3 affected287 at risk
Gastrointestinal hypomotility	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Ileus	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Inflammatory bowel disease	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Melaena	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Nausea	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0012 events2 affected287 at risk
Neutropenic colitis	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected288 at risk EG0011 events1 affected287 at risk
Oesophageal ulcer	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0011 events1 affected287 at risk
Vomiting	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Asthenia	General disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0011 events1 affected287 at risk
Death	General disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected288 at risk EG0012 events2 affected287 at risk
General physical health deterioration	General disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0011 events1 affected287 at risk
Hypothermia	General disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Mucosal inflammation	General disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0013 events3 affected287 at risk
Oedema	General disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Pain	General disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Pyrexia	General disorders	MedDRA 22.1	Systematic Assessment	EG0009 events7 affected288 at risk EG0015 events5 affected287 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0012 events2 affected287 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected288 at risk EG0011 events1 affected287 at risk
Hepatocellular injury	Hepatobiliary disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Hepatotoxicity	Hepatobiliary disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0012 events2 affected287 at risk
Hydrocholecystis	Hepatobiliary disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected288 at risk EG0011 events1 affected287 at risk
Acute graft versus host disease	Immune system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Acute graft versus host disease in skin	Immune system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Engraftment syndrome	Immune system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Graft versus host disease in gastrointestinal tract	Immune system disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected288 at risk EG0012 events2 affected287 at risk
Graft versus host disease in liver	Immune system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Haemophagocytic lymphohistiocytosis	Immune system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Immune reconstitution inflammatory syndrome	Immune system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Kidney transplant rejection	Immune system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Abdominal abscess	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Abdominal sepsis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Anal infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Appendicitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Aspergillus infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0012 events2 affected287 at risk
Atypical pneumonia	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Bacteraemia	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0005 events5 affected288 at risk EG0013 events3 affected287 at risk
Bacterial pericarditis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Bacterial sepsis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Brain abscess	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0006 events6 affected288 at risk EG0016 events6 affected287 at risk
Candida sepsis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Cellulitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Cellulitis pharyngeal	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Cerebral aspergillosis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Citrobacter sepsis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Clostridial infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0012 events2 affected287 at risk
Clostridium difficile infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected288 at risk EG0011 events1 affected287 at risk
Corona virus infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Cystitis viral	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected288 at risk EG0012 events2 affected287 at risk
Cytomegalovirus viraemia	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Device related infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Device related sepsis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0011 events1 affected287 at risk
Disseminated cytomegaloviral infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Diverticulitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Emphysematous cholecystitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Endocarditis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Endocarditis bacterial	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Enteritis infectious	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Enterobacter pneumonia	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0012 events2 affected287 at risk
Enterobacter sepsis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Enterococcal bacteraemia	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0011 events1 affected287 at risk
Enterococcal sepsis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0004 events3 affected288 at risk EG0012 events2 affected287 at risk
Escherichia sepsis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0012 events2 affected287 at risk
Febrile infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected288 at risk EG0011 events1 affected287 at risk
Fungal infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Gastroenteritis norovirus	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Hepatosplenic candidiasis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Herpes zoster	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Infectious pleural effusion	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Influenza	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected288 at risk EG0011 events1 affected287 at risk
Intervertebral discitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Klebsiella bacteraemia	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0013 events3 affected287 at risk
Klebsiella sepsis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Lower respiratory tract infection bacterial	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Lower respiratory tract infection viral	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Meningitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Mucormycosis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Muscle abscess	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Neutropenic sepsis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Nocardiosis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Peritonitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0011 events1 affected287 at risk
Pneumonia	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG00027 events23 affected288 at risk EG00112 events12 affected287 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0011 events1 affected287 at risk
Pneumonia cytomegaloviral	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected288 at risk EG0011 events1 affected287 at risk
Pneumonia fungal	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0012 events2 affected287 at risk
Pneumonia klebsiella	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0012 events2 affected287 at risk
Pneumonia pseudomonal	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0011 events1 affected287 at risk
Pneumonia respiratory syncytial viral	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Pneumonia viral	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Pseudomembranous colitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected288 at risk EG0010 events0 affected287 at risk
Pseudomonal bacteraemia	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0011 events1 affected287 at risk
Pseudomonal sepsis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0011 events1 affected287 at risk
Pulmonary mycosis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0011 events1 affected287 at risk
Pulmonary sepsis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Pyelonephritis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Relapsing fever	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Renal graft infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Respiratory tract infection fungal	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Sepsis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG00010 events10 affected288 at risk EG0017 events7 affected287 at risk
Sepsis syndrome	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Septic shock	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG00016 events16 affected288 at risk EG00116 events16 affected287 at risk
Sinusitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0011 events1 affected287 at risk
Sinusitis fungal	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0012 events2 affected287 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Systemic candida	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected288 at risk EG0011 events1 affected287 at risk
Urinary tract infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected288 at risk EG0010 events0 affected287 at risk
Urinary tract infection enterococcal	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Varicella zoster virus infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Procedural pneumothorax	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Alanine aminotransferase increased	Investigations	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected288 at risk EG0013 events3 affected287 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected288 at risk EG0012 events2 affected287 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Blood creatinine increased	Investigations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Cytomegalovirus test positive	Investigations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected288 at risk EG0010 events0 affected287 at risk
Liver function test increased	Investigations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Neutrophil count decreased	Investigations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Transaminases increased	Investigations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected288 at risk EG0011 events1 affected287 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected288 at risk EG0010 events0 affected287 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Tumour lysis syndrome	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Muscle twitching	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Acute lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected288 at risk EG0011 events1 affected287 at risk
Acute lymphocytic leukaemia recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected288 at risk EG0013 events3 affected287 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0007 events7 affected288 at risk EG00112 events12 affected287 at risk
Acute myeloid leukaemia recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected288 at risk EG0010 events0 affected287 at risk
B-cell lymphoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
B-cell type acute leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Blast crisis in myelogenous leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0012 events2 affected287 at risk
Diffuse large B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Diffuse large B-cell lymphoma refractory	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Hepatic cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Leukaemia recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected288 at risk EG0010 events0 affected287 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Neuroendocrine tumour of the lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0012 events2 affected287 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected288 at risk EG0011 events1 affected287 at risk
Precursor T-lymphoblastic lymphoma/leukaemia refractory	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Primary mediastinal large B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Tumour associated fever	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Brain oedema	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0012 events2 affected287 at risk
Cerebral disorder	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected288 at risk EG0012 events2 affected287 at risk
Cerebral infarction	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Dizziness	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Encephalopathy	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected288 at risk EG0015 events5 affected287 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0011 events1 affected287 at risk
Headache	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0011 events1 affected287 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Paraesthesia	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Seizure	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0012 events2 affected287 at risk
Status epilepticus	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Syncope	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected288 at risk EG0011 events1 affected287 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0011 events1 affected287 at risk
Wernicke's encephalopathy	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Bipolar I disorder	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Confusional state	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected288 at risk EG0010 events0 affected287 at risk
Hallucination	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected288 at risk EG0011 events1 affected287 at risk
Mental status changes	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Suicide attempt	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0009 events9 affected288 at risk EG0015 events5 affected287 at risk
Cystitis haemorrhagic	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Haematuria	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected288 at risk EG0012 events2 affected287 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0013 events3 affected287 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected288 at risk EG0010 events0 affected287 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected288 at risk EG0010 events0 affected287 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected288 at risk EG0011 events1 affected287 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected288 at risk EG0010 events0 affected287 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected288 at risk EG0011 events1 affected287 at risk
Pulmonary alveolar haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected288 at risk EG0011 events1 affected287 at risk
Pulmonary artery thrombosis	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Pulmonary cavitation	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0012 events2 affected287 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected288 at risk EG0012 events2 affected287 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0013 events3 affected287 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0014 events4 affected287 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG00010 events10 affected288 at risk EG0018 events7 affected287 at risk
Dermatitis exfoliative generalised	Skin and subcutaneous tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Toxic skin eruption	Skin and subcutaneous tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected287 at risk
Aortic aneurysm	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0011 events1 affected287 at risk
Hypotension	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected288 at risk EG0010 events0 affected287 at risk
Shock	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected287 at risk

ID	Term
D001423	Bacterial Infections and Mycoses
D007239	Infections
D055732	Pulmonary Aspergillosis
D001228	Aspergillosis
D000072742	Invasive Fungal Infections
D008172	Lung Diseases, Fungal
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Posaconazole	Participants received 300 mg posaconazole (POS) intravenous (IV) twice per day (BID) on Day 1, and then received 300 mg POS IV plus placebo IV once per day (QD) starting on Day 2 until clinically stable when participants transitioned to oral POS tablets plus oral placebo tablets QD for up to 12 weeks of treatment. Most participants were expected to initiate treatment with IV therapy and transition to oral therapy as clinically indicated, with some participants initiating treatment with oral therapy, per clinical judgment.	99	293	178	288	232	288
EG001	Voriconazole	Participants received 6 mg/kg voriconazole (VOR) IV twice per day (BID) on Day 1, and then received 4 mg/kg VOR IV BID on Day 2 until clinically stable when participants transitioned to oral therapy with VOR capsules or VOR placebo capsules BID for up to 12 weeks of treatment. Most participants were expected to initiate treatment with IV therapy and transition to oral therapy as clinically indicated, with some participants initiating treatment with oral therapy, per clinical judgment.	99	292	172	287	225	287